Monitoring the Pulse of Health Care and Life Sciences
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On November 15, 2024, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) jointly announced an extension of current COVID-era tele-prescribing flexibilities for another year – through December 31, 2025 – via…
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42…
On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of action” with respect to the prescribing of controlled substances via telemedicine. DEA is issuing a limited extension in order to give itself more time to finalize new standards governing tele-prescribing of controlled substances.Continue Reading DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024
The Illinois House of Representatives recently voted in favor of passing HB 2222 (“the Bill”), which, if enacted, would amend the Illinois Antitrust Act to add new reporting requirements for certain transactions, including mergers, acquisitions, and contracting affiliations. These heightened requirements would impact healthcare facilities and provider organizations starting on January 1, 2024. The Bill is currently under consideration in the Illinois Senate and would need to be passed by the Illinois Senate and then signed by Illinois Governor J.B. Pritzker in order to be enacted into law.Continue Reading Pending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers, legislative changes, and flexibilities that have been established during the PHE. The government previously announced that the PHE will expire at the end of the day on May 11, 2023. CMS is providing this guidance as part of efforts to ease the transition for health care providers, patients, and other industry stakeholders away from pandemic-era policies and practices tied to PHE authorities. CMS emphasizes that many of the waivers and flexibilities are or will become permanent or extended, and others are intended to end on or soon following May 11, 2023.
Below please find a summary of key guidance provided by CMS in the Fact Sheet and in related CMS PHE guidance documents issued recently:Continue Reading CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued changes to the Medicare Shared Savings Program to advance CMS’ broader strategy of growth, alignment, and equity. To improve the overall operations of the Shared Savings Program, CMS is finalizing changes that, among other things, will impact payment and Accountable Care Organization (ACO) beneficiary assignment, update quality reporting and performance requirements, and reduce the administrative burden for ACOs.Continue Reading Key Changes to the Medicare Shared Savings Program
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued final rules concerning the 2023 Hospital Outpatient Prospective Payment System (OPPS) payment rates and 2023 Medicare Physician Fee Schedule (PFS). These final rules implement various updates and policy changes for Medicare payments under the PFS and OPPS, and made significant updates to the Medicare Shared Savings Program (MSSP), which go into effect on or after January 1, 2023. We summarize the key changes below and will elaborate on these rules in future posts.Continue Reading CMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee Schedule
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.
Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff:
Continue Reading CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers
On March 14, 2021, Connecticut Governor Lamont issued Executive Order 10C (EO 10C), which extends provisions of Public Act 20-2 (PA 20-2), a law passed by the Connecticut legislature in July 2020 that “provided additional flexibility for the delivery of telehealth services and insurance coverage of these services” but was scheduled to expire March 15, 2021. As a result of EO 10C, the provisions of PA 20-2 that were scheduled to expire on March 15 will remain in effect through April 20, 2021, in part to give the state legislature more time to “address the ongoing need for” expanded access to telehealth services.
Continue Reading Connecticut Extends Expansion of Access to Telehealth Services
On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil…
